Condition category
Musculoskeletal Diseases
Date applied
12/09/2006
Date assigned
30/10/2006
Last edited
12/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lars Alfredsson

ORCID ID

Contact details

Karolinska Instituet
Institute of Environmental Medicine
Box 210
Stockholm
SE-171 77
Sweden
lars.alfredsson@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

The BJÖRN-study

Study hypothesis

The hypothesis tested was: naprapathic treatment is more effective for patients with non-specific pain and disability in low back and/or neck/shoulder, than evidence-based advices provided by a physician.

Ethics approval

Ethics committee approval was received on the 29th of December 2003 from the Karolinska Institutet (dnr: 03-657)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Neck, shoulder or low back pain

Intervention

Naprapathy (index group): One out of eight naprapaths gave a maximum of six treatments within six weeks in his/her own clinic. The naprapath decided how the treatment sequences should be performed and precise notes about the treatment, advises, progress and possible adverse reactions, were kept. Each appointment lasted for about 45 minutes. Naprapathy, founded by Dr Oakley Smith in the beginning of the 20th century, is a manual therapy for soft tissues and joints aimed at decreasing pain and re-establishing musculoskeletal function. Treatment with Naprapathy means that every patient is given an individual combination of manual naprapathic techniques as manipulation and mobilisation of joints as well as stretching and massage for the muscles. In addition to the manual treatments, preventive and rehabilitating physical activity and ergonomic advices often are given.

Evidence Based Care provided by a physician (control group): One out of four physicians gave evidence based care in direct conjunction with the physical examination all participating patients got prior to the randomisation (an additional 15 minutes). The evidence-based care (“gold standard”) involved evidence-based advice and support by the physician according to guidelines that aimed to empower the patient in the understanding of the fact that the best prognosis for recovery is received by living as normal a life as possible, including work and physical activities. The aim of the consultation was empowerment of the patient’s belief in and faith in his/her own capacity to handle and cope with the pain. A booklet and exercises conformed to the patients conditions were given. Precise notes were kept and a second consultation (approximately 15 minutes) after three weeks was scheduled. The patient was told that additional consultation could be offered if necessary.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain and disability, measured by the Chronic Pain Questionnaire (CPQ)

Secondary outcome measures

Health status, , measured by the Medical Outcomes Study Short Form-36 Health Survey (SF-36) at 26 and 52 weeks, incorporating
1. Recovery
2. Quality of life
3. General health
4. Sick leave
5. Economical aspects in short and long term

Overall trial start date

07/03/2005

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Participants were assembled mainly among employees at two big companies in Stockholm, Sweden (in total around 40,000 persons) during the period March to September 2005.

The inclusion criteria was a present non-specific pain in back or neck/shoulder of the kind that brought about marked disability at work and/or in leisure time, for at least two weeks.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Pregnancy
2. Specific diagnose as acute slipped disc or spinal stenos
3. Recently have been exposed to naprapathic treatment or evidence based physician consultation (the preceding two months) or other manual therapy with the exception of massage (the preceding month)
4. Surgery in the painful area
5. Red flags (e.g. serious disease in back or neck and recent trauma in the area)
6. Not able to understand Swedish

Recruitment start date

07/03/2005

Recruitment end date

30/09/2006

Locations

Countries of recruitment

Sweden

Trial participating centre

Karolinska Instituet
Stockholm
SE-171 77
Sweden

Sponsor information

Organisation

Karolinska Institutet (Sweden)

Sponsor details

Nobels väg 5
Solna
Stockholm
SE-171 77
Sweden
+46 8 524 800 00
info@ki.se

Sponsor type

University/education

Website

http://www.ki.se

Funders

Funder type

Government

Funder name

Swedish Research Council (Sweden) (ref: K2005-27VK-15355-01A)

Alternative name(s)

Swedish Research Council, VR

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Stockholm County Council (Sweden) (ref: 20050585)

Alternative name(s)

Stockholm County Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Uppsala County Council (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Capio (Sweden) (ref: 626)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Naprapathic Association (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17515742
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20137063

Publication citations

  1. Results

    Skillgate E, Vingård E, Alfredsson L, Naprapathic manual therapy or evidence-based care for back and neck pain: a randomized, controlled trial., Clin J Pain, 2007, 23, 5, 431-439, doi: 10.1097/AJP.0b013e31805593d8.

  2. Results

    Skillgate E, Bohman T, Holm LW, Vingård E, Alfredsson L, The long-term effects of naprapathic manual therapy on back and neck pain - results from a pragmatic randomized controlled trial., BMC Musculoskelet Disord, 2010, 11, 26, doi: 10.1186/1471-2474-11-26.

Additional files

Editorial Notes